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Antibiotic Prophylaxis in Laparoscopic Cholecystectomy

This study has suspended participant recruitment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01888822
First Posted: June 28, 2013
Last Update Posted: April 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Erasmo Spaziani, University of Roma La Sapienza
  Purpose
The trial aims to assess the value of two-regimen antibiotic prophylaxis versus placebo in elective laparoscopic cholecystectomy.

Condition Intervention Phase
Cholelithiasis Drug: Ciprofloxacin Drug: Ampicillin-sulbactam Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ciprofloxacin, Ampicillin-sulbactam and Placebo Prophylaxis in Laparoscopic Cholecystectomy. A Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by Erasmo Spaziani, University of Roma La Sapienza:

Primary Outcome Measures:
  • Surgical site infection [ Time Frame: 30 days after operation ]
    Surgical site infection defined according to the Centre of Disease Control (CDC) classification, recorded as 'yes' or 'no'.


Secondary Outcome Measures:
  • Extra-abdominal infections [ Time Frame: 30 days ]
    Extra-abdominal infections defined according to the CDC classification, recorded as 'yes' or 'no'.

  • Adverse events. [ Time Frame: 30 days ]
    Adverse events, defined as allergic reactions to antibiotics.

  • Quality of life [ Time Frame: 30 days ]
    Quality of life measured with the 36-Item Short Form Health Survey


Estimated Enrollment: 138
Study Start Date: June 2013
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Intravenous infusion of 0.9% Sodium Chloride 250 ml during induction of anesthesia and before laparoscopic cholecystectomy.
Drug: Placebo
Prophylactic placebo infusion before elective laparoscopic cholecystectomy
Active Comparator: Ampicillin-sulbactam
Intravenous infusion of 3gr ampicillin-sulbactam in 0.9% Sodium Chloride 250 ml during induction of anesthesia and before laparoscopic cholecystectomy.
Drug: Ampicillin-sulbactam
Prophylactic ampicillin-sulbactam infusion before elective laparoscopic cholecystectomy
Active Comparator: Ciprofloxacin
Intravenous infusion of 400 mg ciprofloxacin in 0.9% Sodium Chloride 250 ml during induction of anesthesia and before laparoscopic cholecystectomy.
Drug: Ciprofloxacin
Prophylactic ciprofloxacin infusion before elective laparoscopic cholecystectomy

Detailed Description:
All patients enrolled will be submitted to laparoscopic cholecystectomy. The primary aim of the trial will be to assess the role of prophylactic i.v. infusion of ampicillin-sulbactam, ciprofloxacin, and placebo to reduce the rate of surgical site infection.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • elective laparoscopic cholecystectomy;
  • patients suffering from gallbladder stones,chronic cholecystitis, cholesterolosis, or gallbladder polyps.

Exclusion Criteria:

  • acute cholecystitis;
  • acute cholangitis;
  • acute pancreatitis;
  • pregnant or lactating women;
  • antibiotic allergy;
  • antibiotic therapy within 48 hours to 7 days prior to surgery;
  • clinically active infection at the moment of surgery;
  • evidence of common bile duct stones;
  • contraindications for laparoscopic cholecystectomy;
  • no other additional procedure;
  • indication of obligatory antibiotic prophylaxis because the medical condition was different from biliary disease (immunosuppression, corticoid use, etc).
  • patients unable to give informed consent.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01888822


Locations
Italy
Sapienza University of Rome- Polo Pontino
Terracina, Latina, Italy, 04019
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
Study Director: Erasmo Spaziani, MD, PhD Sapienza University of Rome
  More Information

Publications:
Responsible Party: Erasmo Spaziani, Professor, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT01888822     History of Changes
Other Study ID Numbers: MarPic63
First Submitted: June 13, 2013
First Posted: June 28, 2013
Last Update Posted: April 26, 2016
Last Verified: June 2013

Keywords provided by Erasmo Spaziani, University of Roma La Sapienza:
Laparoscopic cholecystectomy
Prophylactic antibiotics

Additional relevant MeSH terms:
Cholelithiasis
Cholecystolithiasis
Gallstones
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical
Anti-Bacterial Agents
Ciprofloxacin
Ampicillin
Sulbactam
Sultamicillin
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
beta-Lactamase Inhibitors


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